FDA.reportPublic FDA data

Application 076353

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo
003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-8960Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8960Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8960Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8960Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8961Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8961Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8961Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8961Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8962Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8962Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8962Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
0406-8962Dextroamphetamine Sulfatedextroamphetamine sulfateSpecGx LLCANDACurrent
60687-150Dextroamphetamine Sulfatedextroamphetamine sulfateAmerican Health PackagingANDACurrent
60687-150Dextroamphetamine Sulfatedextroamphetamine sulfateAmerican Health PackagingANDACurrent